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CDER branch chief Alicia M. Mozzachio says inadequate lab controls leads FDAs list of common violations seen at international acti...[ Price : $8.95]
FDA issues a draft guidance to help applicants develop the Patient Counseling Information section in drug labeling.[ Price : $8.95]
Federal Register Final rule: FDA amends the animal drug regulations to reflect August approvals.[ Price : $8.95]
Federal Register Notice: FDAs Antiviral Drugs Advisory Committee will meet 10/24 to discuss a Janssen NDA for simeprevir to treat ...[ Price : $8.95]
FDA approves a Sun Pharmaceutical Industries ANDA for a generic version of Prevacid (lansoprazole) delayed-release capsules USP, 1...[ Price : $8.95]
Federal Register Notice: FDA submits a proposed collection of information on requests for Clinical Laboratory Improvement Amendmen...[ Price : $8.95]
Federal Register Notice: FDAs Antiviral Drugs Advisory Committee will meet 10/25 to discuss a Gilead Sciences NDA for treating chr...[ Price : $8.95]
FDA grants 510(k) clearance to Lumenis Ltd. for the ResurFX, a fractional non-ablative laser module for skin resurfacing.